Roll-Over Protocol To Provide Atv And/Or Truvada For Extended Access
- Conditions
- HIV
- Interventions
- Registration Number
- NCT01003990
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.
- Detailed Description
Provide study drug for patients rolling off BMS ATV clinical trials in countries where these medications are not commercially available.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 710
-
Subjects must provide written informed consent
-
Currently receiving atazanavir (unboosted or boosted with 100 mg ritonavir QD)and/or tenofovir-emtricitabine at time of screening and viral load is
≤ 10,000 copies/mL while on therapy
-
Subjects who are receiving investigational antiretroviral agents through Expanded Access Programs will be allowed to participate following discussion and approval by the BMS Medical Monitor
-
≥ 16 years of age (or minimum age as determined by local regulatory or as legal requirements dictate)
-
Both females of child-bearing potential and males must utilize effective barrier contraception to reduce transmission of sexually transmitted diseases, including HIV. Other contraception in addition to barrier methods are permitted, however interactions between atazanavir and oral contraceptives have not been studied
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study
- WOCBP using a prohibited contraceptive method (no contraceptive methods prohibited in this study. However, caution is warranted with coadministration of oral contraceptives)
- Women who are pregnant or breastfeeding
- Women with a positive pregnancy test on enrollment or prior to study drug administration, with the exception of women rolling over from AI424182, who may still have a positive β-HCG test at the time of enrollment
- All subjects previously discontinued from an atazanavir study for any reason
- Active alcohol or substance abuse sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis
- Any other clinical conditions or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for study, or unable to comply with the dosing requirements
- Any of the following laboratory values:
- a) Serum creatinine ≥ 1.5 times the upper limit of normal,
- b) Liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal,
- Hypersensitivity to any component of the formulation of study drug
- Refer to Section 6.4.1 which details all prohibited therapies
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lopinavir/Ritonavir Tenofovir/Emtricitabine Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC). Atazanavir Atazanavir - Atazanavir/Ritonavir Atazanavir/Ritonavir - Lopinavir/Ritonavir Lopinavir/ritonavir Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).
- Primary Outcome Measures
Name Time Method Number of Participants With Serious Adverse Events (SAEs), Treatment Related SAEs, Treatment Related Adverse Events (AEs), AEs Leading to Discontinuation of Study Therapy, Grade 3 to Grade 4 AEs, Grade 3 to Grade 4 AEs, CDC Class C AIDS Events, or Death Date of First Dose to 30 days post the last dose; approximately 405 weeks) AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AIDS Defining Diagnosis ( CDC Class C AIDS Events) are identified from HIV Related Diagnosis.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Clinical Research Puerto Rico, Inc.
🇵🇷San Juan, Puerto Rico
Sbma Research, Llc
🇺🇸Miami Beach, Florida, United States
St Francis Memorial Hospital
🇺🇸San Francisco, California, United States
Phoenix Body Positive, Inc
🇺🇸Phoenix, Arizona, United States
Rand Schrader Clinic
🇺🇸Los Angeles, California, United States
Infectious Disease Of Indiana, Psc
🇺🇸Indianapolis, Indiana, United States
Cri Of New England
🇺🇸Boston, Massachusetts, United States
Univ Of Kansas Sch Of Med
🇺🇸Wichita, Kansas, United States
Tarrant County Inf Dis Assoc
🇺🇸Fort Worth, Texas, United States
Jemsek Clinic
🇺🇸Huntersville, North Carolina, United States
Local Institution
🇹🇭Chiangmai, Thailand
The Schrader Clinic
🇺🇸Houston, Texas, United States
V.A. Medical Center
🇵🇷San Juan, Puerto Rico
University Of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
St Josephs Cmprhnsv Rsch Inst
🇺🇸Tampa, Florida, United States